Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)
This early-stage clinical trial (Phase 1/2) is testing new combinations of medicines for people with advanced gastric (stomach), gastroesophageal junction, or oesophageal (gullet) cancer. These are cancers that have spread or cannot be removed surgically, and haven't been treated before. The main aim is to find safe doses of these new drug combinations when given alongside a standard cancer drug called pembrolizumab and chemotherapy. Researchers also want to see how well these new combinations might work against the cancer. It's an 'open-label' study, meaning both patients and doctors will know which treatment is being given. The cancer must be 'HER2-negative', which is a type of cancer that doesn't have too much of a specific protein.
At a glance
What is this study about?
This study, called KEYMAKER-U06, is a type of medical research that looks into new ways to treat advanced stomach (gastric), the area where the gullet joins the stomach (gastroesophageal junction), or gullet (oesophageal) cancer. These are cancers that have either spread to other parts of the body (metastatic) or are too advanced to be removed by surgery. The study focuses on people who haven't received treatment for their cancer yet, and whose cancer is 'HER2-negative' – this means their cancer doesn't have a high level of a certain protein, which helps doctors choose the best treatment.
The trial is in its early stages (Phase 1/2). This means that at first, the main goal is to check if new combinations of medicines are safe and to find the right dosage. Once a safe dose is established, the study will then look at how effective these new treatments are in fighting the cancer. The combination treatments involve pembrolizumab, which helps the body's own immune system fight cancer, along with standard chemotherapy and some new investigational drugs.
This study is important because it explores potentially better treatment options for people with this type of advanced cancer. By combining existing treatments with new ones, researchers hope to find more effective ways to manage the disease. It's a stepping stone towards developing new therapies that could improve patients' lives in the future.
Key takeaways
- This study is for advanced stomach or oesophageal cancer that hasn't been treated before.
- It tests new drug combinations, including pembrolizumab and chemotherapy.
- The main goals are to find safe doses and see how well the treatments work.
- Your cancer must be 'HER2-negative' to be eligible.
- It's an early-stage study, meaning these are investigational treatments.
Who may be eligible?
To join this study, you would need to have stomach, gastroesophageal junction, or oesophageal cancer that has spread or is too advanced for surgery, and you haven't received any prior treatment for it. Importantly, tests must show that your cancer is 'HER2-negative', meaning it doesn't have a specific protein marker. You'd also need to be generally well enough to take part, with healthy organ function, and have at least 6 months of life expectancy.
There are also specific medical conditions that might prevent you from joining. For example, if your cancer is a different type (like squamous cell cancer), or if you have certain unresolved side effects from past treatments. If you have conditions like Hepatitis B, Hepatitis C, or HIV, these would need to be well-managed for you to be considered.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your cancer stomach, gastroesophageal junction, or oesophageal cancer?
- Has your cancer spread, or is it too advanced for surgery?
- Have you started any treatment for your cancer yet?
- Are your cancer cells confirmed to be 'HER2-negative'?
- Are you generally well and able to perform daily activities without much difficulty?
What does participation involve?
Taking part in this study would involve regular hospital visits for assessments and to receive the medication. You'll have blood tests, scans, and physical exams to monitor your health and how the treatment is working. Doctors will carefully check for any side effects. The study includes several different medicines given in combination, and some of them are investigational, meaning they are still being tested. The exact schedule of visits and treatments would be explained in detail by the study team. You would initially go through a safety phase where the aim is to find the most suitable dose, followed by a phase to see how well the treatment works. You can stop participating in the study at any time.
Potential risks and benefits
Locations (51)
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)Verified postcodeTucson, United States· Recruiting
- UCLA Hematology/Oncology - Santa Monica ( Site 6905)Verified postcodeLos Angeles, United States· Recruiting
- Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)Verified postcodeLouisville, United States· Completed
- The Cancer and Hematology Centers ( Site 6912)Verified postcodeGrand Rapids, United States· Recruiting
- Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)Verified postcodeEast Syracuse, United States· Recruiting
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)Verified postcodeNew York, United States· Completed
- UPMC Hillman Cancer Center-UPMC ( Site 6904)Verified postcodePittsburgh, United States· Recruiting
- University of Texas MD Anderson Cancer Center ( Site 6920)Verified postcodeHouston, United States· Recruiting
- Liga Norte Riograndense Contra o Câncer ( Site 6303)Verified postcodeNatal, Brazil· Recruiting
- Hospital Nossa Senhora da Conceição ( Site 6301)Verified postcodePorto Alegre, Brazil· Recruiting
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)Verified postcodeSão Paulo, Brazil· Recruiting
- IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)Verified postcodeSão Paulo, Brazil· Recruiting
Common questions
What does 'HER2-negative' mean?
It means your cancer cells don't have too much of a specific protein, which helps doctors decide the best treatments for your cancer type.
What is an 'investigational agent'?
It's a new medicine that is still being tested in clinical trials to see if it's safe and effective before it can be approved for wider use.
What is chemotherapy?
Chemotherapy uses strong medicines to kill cancer cells or stop them from growing.
What is 'Phase 1/2' in a clinical trial?
It means the study is in its early stages. Phase 1 mainly checks for safety and the right dose, while Phase 2 looks at how well the treatment works.
Can I stop participating in the study if I change my mind?
Yes, you can withdraw from the study at any time without having to give a reason, and it won't affect your regular medical care.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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